COLD THERAPY PAIN RELIEF- menthol, unspecified form gel

Cold Therapy Pain Relief by

Drug Labeling and Warnings

Cold Therapy Pain Relief by is a Otc medication manufactured, distributed, or labeled by Walgreen Co., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

When using this product

• use only as directed
• avoid contact with the eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

• you experience pain, swelling or blistering oi the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician
• wash hands after use with cool water

Other information

• store at 20-25°C (68-77°F)
• store in a cool dry place away from direct sunlight

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

Principal Display Panel – 74 mL Bottle Label

Walgreens

Compare to the active ingredient
in Biofreeze® Roll-On††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy
Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

• For the temporary relief of arthritis,
  back pain, sore muscles & joints
• Soothing menthol
• Paraben free

2.5 FL OZ (74 ml)

Principal Display Panel – 89 mL Tube Label

Walgreens

Compare to the active
ingredient in Biofreeze® Gel††

WALGREENS PHARMACIST RECOMMENDED

Cold
Therapy
Pain Relief
Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

• For the temporary relief of arthritis,
  back pain, sore muscles & joints
• Soothing menthol
• Paraben free

3 FL OZ (89 ml)

INGREDIENTS AND APPEARANCE

COLD THERAPY PAIN RELIEF 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0356
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0356-25	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/01/2024
2	NDC: 0363-0356-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2024

Labeler - Walgreen Co. (008965063)

Registrant - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(0363-0356)